FDA.reportPublic FDA data

Health Design Forefoot Reliever Post Op Shoe

Primary DI
20609271001149
Brand
Health Design Forefoot Reliever Post Op Shoe
Company
DARCO INTERNATIONAL, INC.
Model
HD-PO-FR5
Catalog number
HD-PO-FR5
Device description
Extra-Large Black
Published
2023-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KNPORTHOSIS, CORRECTIVE SHOE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNPOrthosis, Corrective ShoePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10609271001142PackageGS112In Commercial Distribution
20609271001149PackageGS136In Commercial Distribution
00609271001145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927100114210609271001142
2060927100114920609271001149
00609271001145006092710011456092710011450609271001145

GMDN Terms#

Term, Definition table
TermDefinition
Orthotic shoe, non-customizedA prefabricated (non-customized) footwear designed as a shoe intended to support, align, prevent, and compensate for or correct deformities of the feet to help improve function and/or for post-operative therapy. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184231298
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0060927120013516'' DLX POST-OP KNEE IMMOB462-0012-30462-0012-302023-02-08
0060927120015916'' DLX POST-OP KNEE IMMOB462-0012-40462-0012-402023-02-08
0060927120017316'' DLX POST-OP KNEE IMMOB462-0012-50462-0012-502023-02-08
0060927120018016'' DLX POST-OP KNEE IMMOB462-0012-60462-0012-602023-02-08
0060927120019716'' DLX POST-OP KNEE IMMOB462-0012-70462-0012-702023-02-08
0060927120033320'' DLX POST-OP KNEE IMMOB462-0014-30462-0014-302023-02-08
0060927120035720'' DLX POST-OP KNEE IMMOB462-0014-40462-0014-402023-02-08
0060927120037120'' DLX POST-OP KNEE IMMOB462-0014-50462-0014-502023-02-08
0060927120038820'' DLX POST-OP KNEE IMMOB462-0014-60462-0014-602023-02-08
0060927120039520'' DLX POST-OP KNEE IMMOB462-0014-70462-0014-702023-02-08
0060927121050920'' DLX 3-PANEL KNEE IMMOB462-0025-10462-0025-102023-02-08
0060927121060820'' DLX 3-PANEL KNEE IMMOB462-0026-10462-0026-102023-02-08
0060927121080620'' DLX 3-PANEL KNEE IMMOB462-0028-10462-0028-102023-02-08
00609271610774"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (small)"E59410E594102023-02-08
00609271610781"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (medium)"E59411E594112023-02-08
00609271610798"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (large)"E59412E594122023-02-08
00609271610804"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (x-large)"E59413E594132023-02-08
00609271610811"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (small)"E59414E594142023-02-08
00609271610828"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (medium)"E59415E594152023-02-08
00609271610835"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (large)"E59416E594162023-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00609271120297POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120334POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120501POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271000353KERRAPED PLUS™ All Purpose BootDarco (Europe) GmbHKNP2023-02-13
00609271000360KERRAPED PLUS™ All Purpose BootDarco (Europe) GmbHKNP2023-02-13
00609271000377KERRAPED PLUS™ All Purpose BootDarco (Europe) GmbHKNP2023-02-13
00609271000384KERRAPED PLUS™ All Purpose BootDarco (Europe) GmbHKNP2023-02-13
00609271001428DARCO® Relief Dual® PlusDarco (Europe) GmbHKNP2023-02-13
00609271001435DARCO® Relief Dual® PlusDarco (Europe) GmbHKNP2023-02-13
00609271001442DARCO® Relief Dual® PlusDarco (Europe) GmbHKNP2023-02-13
00609271001459DARCO® Relief Dual® PlusDarco (Europe) GmbHKNP2023-02-13
00609271001466DARCO® Relief Dual® PlusDarco (Europe) GmbHKNP2023-02-13
00609271001473DARCO® Relief Dual® PlusDarco (Europe) GmbHKNP2023-02-13
00609271001480DARCO® Relief Dual® PlusDarco (Europe) GmbHKNP2023-02-13
00609271001497DARCO® Relief Dual® PlusDarco (Europe) GmbHKNP2023-02-13
00609271010116DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271010215DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271010314DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271010413DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271013117DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271013216DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271013315DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271016514DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271230569DARCO® GentleStep™ ShoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271230576DARCO® GentleStep™ ShoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271230583DARCO® GentleStep™ ShoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271230613DARCO® GentleStep™ ShoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271230620DARCO® GentleStep™ ShoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271230637DARCO® GentleStep™ ShoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271230668DARCO® GentleStep™ ShoeDARCO INTERNATIONAL, INC.KNP2023-02-13